Notices of shortages or discontinuations should be provided under the new Regulation at least six months before the anticipated interruption or discontinuation, except in circumstances where such is not possible. The manufacturer is required to specify the reasons for the interruption or discontinuation to the competent authorities.
The economic operators who receive this information are required “without undue delay” to inform any other economic operators, healthcare institutions and healthcare professionals of the anticipated interruption or discontinuation. Economic operators are already required to achieve an appropriate level of traceability as to the devices they sell, such that they are required to be able to identify those who they supplied.
We expect more information on this new regulation in the form of a guidance in the near term. The EU Medical Device Coordination Group is currently working on a "questions and answers" document to facilitate a better understanding of this regulation.
About the author: Robert Kerwin is general counsel to IAMERS and IAMERS representative to the EU MDCG interest group on Post-Market Surveillance and Vigilance.
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